Methods and Systems for Controlling an Infusion Pump

ABSTRACT

A system for pairing a controller and an infusion pump is disclosed. The system includes an infusion pump, a controller device and a user interface residing on both the infusion pump and the controller. The user interface includes a pairing mode for enabling wireless communication between the infusion pump and the controller device, wherein the user interface requires both the infusion pump and the controller to be in the pairing mode simultaneously. Also, a method of changing a power source in an infusion pump is disclosed. The method includes placing the infusion pump in idle mode wherein the infusion pump stops delivery. Removing the first power source from the infusion pump. Replacing the first power source with a second power source in the infusion pump, and maintaining the insulin on board during the changing of the first power source with the second power source.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation Application of U.S. patentapplication Ser. No. 12/416,662, filed on Apr. 1, 2009 and entitledMethods and Systems for Controlling an Infusion Pump, now U.S. Pat. No.9,132,227, issued Sep. 15, 2015 (Attorney Docket No. G98), which claimspriority from the following U.S. Provisional Patent Applications, bothof which are incorporated by reference herein in their entireties:

Ser. No. 61/041,291, filed on Apr. 1, 2008 and entitled Methods andSystems for Controlling a Medical Device (Attorney Docket No. F76); and

Ser. No. 61/165,592 filed on Apr. 1, 2009 and entitled Methods andSystems for Controlling a Medical Device (Attorney Docket No. H24).

TECHNICAL FIELD

The present invention relates to infusion pumps and more particularly,to methods and systems for controlling an infusion pump.

BACKGROUND INFORMATION

Many potentially valuable medicines or compounds, including biologicals,are not orally active due to poor absorption, hepatic metabolism orother pharmacokinetic factors. Additionally, some therapeutic compounds,although they may be orally absorbed, are sometimes required to beadministered so often it is difficult for a patient to maintain thedesired schedule. In these cases, parenteral delivery is often employedor could be employed.

Effective parenteral routes of drug delivery, as well as other fluidsand compounds, such as subcutaneous injection, intramuscular injection,and intravenous (IV) administration include puncture of the skin with aneedle or stylet. Insulin is an example of a therapeutic fluid that isself-injected by millions of people living with diabetes. Users ofparenterally delivered drugs may benefit from a wearable device thatwould automatically deliver needed drugs/compounds over a period oftime.

To this end, there have been efforts to design portable and wearabledevices for the controlled release of therapeutics. Such devices areknown to have a reservoir such as a cartridge, syringe, or bag, and tobe electronically controlled. These devices suffer from a number ofdrawbacks. Reducing the size, weight and cost of these devices is alsoan ongoing challenge.

Additionally, many of these devices require frequent and directinteraction between the device and the user, or the device and acaregiver. Thus, in these cases, it is often desired that the device beworn clipped to clothing or a belt, or in a pocket, thus beingaccessible in any situation. However, this is not always practical orpossible. Thus, there is a desire for a device that may be controlled bya remote device such that the user or caregiver does not requirefrequent direct interaction.

Further, safety is an ongoing concern with any medical device. Thus,systems and methods that impart added safety to the user are desired.

SUMMARY

In accordance with one aspect of the present invention, a system forpairing a controller and an infusion pump is disclosed. The systemincludes an infusion pump, a controller device and a user interfaceresiding on both the infusion pump and the controller. The userinterface includes a pairing mode for enabling wireless communicationbetween the infusion pump and the controller device, wherein the userinterface requires both the infusion pump and the controller to be inthe pairing mode simultaneously.

Some embodiments of this aspect of the present invention may include oneor more of the following. Where the controller includes a display. Wherethe infusion pump includes a display. Where both the controller and theinfusion pump include a display. Where the pairing mode further includesa timeout feature, wherein the pairing mode will timeout if the pairingis not completed within a predetermined time. Where the pairing modefurther includes an indicator to indicate the user interface has found adevice in which to pair, the indicator comprising a serial number. Wherethe pairing mode requires the infusion pump and the controller to be setto the same glucose units.

In accordance with one aspect of the present invention, a method ofchanging a power source in an infusion pump is disclosed. The methodincludes placing the infusion pump in idle mode wherein the infusionpump stops delivery. Removing the first power source from the infusionpump. Replacing the first power source with a second power source in theinfusion pump, and maintaining the insulin on board during the changingof the first power source with the second power source.

Some embodiments of this aspect of the present invention may include oneor more of the following. Where the method further includes sending anotification when the time between the first power source being removedand the second power source being replaced exceeds a threshold.

In accordance with one aspect of the present invention, a system fordetermining the internal temperature of an infusion pump. The systemincludes an infusion pump, the infusion pump including a temperaturesensor. The temperature sensor located such that it may determine theinternal temperature of the infusion pump and send information to aprocessor in the infusion pump. When the temperature either exceeds apredetermined maximum threshold, or falls below a predetermined minimumthreshold, the infusion pump notifies the user.

These aspects of the invention are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the appended claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reading the following detailed description, takentogether with the drawings wherein:

FIGS. 1A-1B are front and back isometric views of one embodiment of aninfusion pump assembly;

FIGS. 1C-1E are side and front views of one embodiment of an infusionpump assembly of FIG. 1;

FIG. 1F is a front isometric view of one embodiment of an infusion pumpassembly of FIG. 1;

FIGS. 2A-2D are various view of an exemplary embodiment of an infusionpump assembly;

FIG. 3 is an illustrative view of one embodiment of a remote controlleror companion assembly;

FIG. 4 is a diagrammatic view of the infusion pump assembly of FIG. 1;

FIGS. 5A-5C shows exemplary embodiments of select Time and Date Wizardscreens according to one embodiment;

FIG. 6 shows an exemplary embodiment of the Cancel Changes ConfirmationScreen;

FIGS. 7A-7F shows an exemplary embodiment of at least a selection of thepair device screens;

FIGS. 8A-8B shows an exemplary embodiment of at least a selection of theinsulin profile screens;

FIGS. 9A-9B shows an exemplary embodiment of at least a selection of thedisplay screens;

FIGS. 10A-10E shows an exemplary embodiment of at least a selection ofthe home screens;

FIGS. 11A-11B shows an exemplary embodiment of at least a selection of1U DROP screens;

FIG. 12 shows an exemplary embodiment of at least a selection of LOCKEDITEMS screens;

FIGS. 13A-13B shows an exemplary embodiment of at least a selection ofWARNING screens;

FIGS. 14A-14B shows an exemplary embodiment of at least a selection ofCompanion WARNING screens;

FIG. 15 shows an exemplary embodiment of at least a selection ofCompanion Temporary Lockout;

FIG. 16 shows an exemplary embodiment of at least a selection of Radioscreens;

FIG. 17 shows an exemplary embodiment of at least one alert, reminderand recoverable screens;

FIGS. 18A-18B shows an exemplary embodiment of at least a selection ofREMINDER and SET SLEEP TIME screens according to an exemplaryembodiment;

FIGS. 19A-19E shows exemplary embodiments of at least a selection ofALARM screens;

FIGS. 20A-20I shows exemplary embodiments of at least a selection ofALERT screens;

FIGS. 21A-21B show exemplary embodiments of at least a selection ofREMINDER screens;

FIG. 22 shows an exemplary embodiment of at least a selection of screensfor setting the Frequency of a SITE CHANGE Care Comment;

FIGS. 23A-23B, show exemplary embodiments of at least a selection ofBOLUS screens;

FIGS. 24A-24D shows exemplary embodiments of at least a selection ofWARNING and CONFIRM screens;

FIG. 25 shows an exemplary embodiment of at least a selection of HISTORYscreens;

FIG. 26 shows an exemplary embodiment of at least a selection of REPORTSscreens;

FIG. 27 shows an exemplary embodiment of at least a selection of DIARYscreens;

FIG. 28 shows an exemplary embodiment of at least a selection of DAILYTHERAPY screens;

FIGS. 29A-29B shows an exemplary embodiment of at least a selection ofEVENT SUMMARY screens;

FIG. 30 shows an exemplary embodiment of at least a selection of ALARMSUMMARY screens;

FIG. 31 shows an exemplary embodiment of at least a selection of SENDDIARY screens;

FIG. 32 shows an exemplary embodiment of at least a selection of screensrelated to the PC Connection;

FIG. 33 shows an exemplary embodiment of at least a selection of screensrelated to the diary log transfer to a PC; and

FIGS. 34A-34D shows an exemplary embodiment of at least a selection ofscreens related to the diary log transfer to a PC.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Definitions

As used in this description and the accompanying claims, the followingterms shall have the meanings indicated, unless the context otherwiserequires:

A “device” shall mean a medical device, which includes, but is notlimited to, an infusion pump and/or a controller, i.e., a device forwireless control of another medical device. In some embodiments, theword “device” is used interchangeably with “pump”, “infusion pump”and/or “controller” and/or “Companion” and/or “remote controller device”and/or “remote controller assembly”.

A “Companion” shall mean a device for wireless control of anothermedical device. In the exemplary embodiments, the Companion may alsoinclude a glucose meter/strip reader.

An “input” of a device includes any mechanism by which a user of thedevice or other operator/caregiver may control a function of the device.User inputs may include mechanical arrangements (e.g., switches,pushbuttons, jogwheel(s)), electrical arrangements (e.g., a slider,touch screen), wireless interfaces for communication with a remotecontroller (e.g., RF, infrared), acoustic interfaces (e.g., with speechrecognition), computer network interfaces (e.g., USB port), and othertypes of interfaces.

A “button” in the context of an input such as the so-called “bolusbutton” discussed below may be any type of user input capable ofperforming a desired function, and is not limited to a pushbutton, aslider, switch, touch screen or a jog wheel.

An “alarm” includes any mechanism by which an alert may be generated toa user or third party. Alarms may include audible alarms (e.g., aspeaker, a buzzer, a speech generator), visual alarms (e.g., an LED, anLCD screen), tactile alarms (e.g., a vibrating element), wirelesssignals (e.g., a wireless transmission to a remote controller orcaretaker), or other mechanism. Alarms may be generated using multiplemechanisms simultaneously, concurrently, or in a sequence, includingredundant mechanisms (e.g., two different audio alarms) or complementarymechanisms (e.g., an audio alarm, a tactile alarm, and a wirelessalarm).

“Fluid” shall mean a substance, a liquid for example, that is capable offlowing through a flow line.

A “user” includes a person or animal who receives fluid from a fluiddelivery device, whether as part of a medical treatment or otherwise, ora caregiver or third party involved in programming the device orotherwise interacting with the device to infuse fluid to another.

“Cannula” shall mean a disposable device capable of infusing fluid to auser. A cannula as used herein may refer to a traditional cannula or toa needle.

“Disposable” refers to a part, device, portion or other that is intendedto be used for a fixed duration of time, then discarded and replaced.

“Reusable” refers to a portion that is intended to have an open-endedduration of use.

“Acoustic volume measurement” shall mean quantitative measurement of arelevant volume using acoustical techniques such as described in U.S.Pat. Nos. 5,349,852 and 5,641,892, as well as other techniquesincorporated by reference herein.

A “temperature sensor” includes any mechanism for measuring temperatureand communicating temperature information to a controller or to a pumpprocessor. The devices described herein may include one or moretemperature sensors for measuring such things as including, but notlimited to, one or more of the following: skin temperature, AVStemperature, ambient temperature, internal temperature and fluidtemperatures.

An exemplary use of embodiments of the devices, methods and systemsdescribed here is for the delivery of insulin to people living withdiabetes, but other uses include delivery of any fluid, as describedabove. Fluids include analgesics to those in pain, chemotherapy tocancer patients and enzymes to patients with metabolic disorders.Various therapeutic fluids may include small molecules, naturalproducts, peptide, proteins, nucleic acids, carbohydrates,nanoparticulate suspensions, and associated pharmaceutically acceptablecarrier molecules. Therapeutically active molecules may be modified toimprove stability in the device (e.g., by pegylation of peptides orproteins). Although illustrative embodiments herein describedrug-delivery applications, embodiments may be used for otherapplications including liquid dispensing of reagents for high throughputanalytical measurements such as lab-on-chip applications and capillarychromatography. For purposes of description below, terms “therapeutic”,“insulin” or “fluid” are used interchangeably, however, in otherembodiments, any fluid, as described above, may be used. Thus, thedevice and description included herein are not limited to use withtherapeutics.

Some embodiments of the fluid delivery device are adapted for use bypeople living with diabetes and/or their caregivers. Thus, in theseembodiments, the devices, methods and systems work to delivers insulinwhich supplements or replaces the action of the person living withdiabetes' (referred to as the user) pancreatic islet beta cells.Embodiments adapted for insulin delivery seek to mimic the action of thepancreas by providing both a basal level of fluid delivery as well asbolus levels of delivery. Basal levels, bolus levels and timing may beset by the user or a caregiver by using a wireless handheld userinterface or directly by using a pump. Additionally, basal and/or boluslevels may be triggered or adjusted in response to the output of aglucose meter, which in the exemplary embodiments, is integral to thecontroller. In other embodiments, the controller additionally includes aglucose monitoring device which receives data from a blood glucosesensor. In some embodiments, a bolus may be triggered by a user using adesignated button or other input means located on a device, i.e., on thecontroller and/or on an infusion pump. In still other embodiments, thebolus or basal may be programmed or administered through a userinterface located either on the fluid delivery device/infusion pumpand/or on the controller.

With respect to the names given to screens and types of screens, as wellas proper names given to various features, throughout variousembodiments, these terms may vary.

The systems and methods described herein may be used to control aninfusion pump. For purposes of this description, the various embodimentsof the user interface and the infusion pump may be described withreference to an insulin pump, or a pump which infuses insulin. However,it should be understood that the user interface may be on an infusionpump and/or on a controller. Additionally, where the descriptionpertains to an infusion pump “screen”, this “screen” may also appear ona controller, or may appear on a controller in lieu of a pump.

Infusion pumps contemplated by this description include a pump which maypump any fluid, including, but not limited to, a therapeutic fluid,which includes, but is not limited to, insulin. Thus, where thisdescription describes the exemplary embodiment as pertaining to insulin,this is meant merely for descriptive purpose only as the device is notintended to be limited to insulin. Other fluids are also contemplated.

The infusion pump may be any infusion pump, for example, but not limitedto, the pump devices shown and described with respect to FIGS. 1A-1F and2A-2D, and include, but are not limited to, those described in U.S.Publication No. US-2007-0228071, published on Oct. 4, 2007 entitledFluid Delivery Systems and Method; U.S. Publication No. US-2007-0219496,published on Sep. 20, 2007 entitled Pumping Fluid Delivery Systems andMethods Using Force Application Assembly; U.S. Publication No.US-2007-0219480, published on Sep. 20, 2007 entitled Patch-Sized FluidDelivery Systems and Methods; U.S. Publication No. US-2007-0219597,published on Sep. 20, 2007 entitled Adhesive and Peripheral Systems andMethods for Medical Devices; U.S. patent application Ser. No.12/347,985, filed Dec. 31, 2008 and entitled Infusion Pump Assembly;U.S. patent application Ser. No. 12/347,982, filed Dec. 31, 2008 andentitled Wearable Pump Assembly; U.S. patent application Ser. No.12/347,981, filed Dec. 31, 2008 and entitled Infusion Pump Assembly;U.S. Pat. No. 7,306,578, issued on Dec. 11, 2007 and entitled LoadingMechanism for Infusion Pump; U.S. patent application Ser. No.12/249,891, filed Oct. 10, 2008 and entitled Infusion Pump Assembly;U.S. patent application Ser. No. 12/249,882, filed Oct. 10, 2008 andentitled Infusion Pump Assembly; U.S. patent application Ser. No.12/249,636, filed Oct. 10, 2008 and entitled System and Method forAdministering an Infusible Fluid; U.S. patent application Ser. No.12/249,621, filed Oct. 10, 2008 and entitled Occlusion Detection Systemand Method; U.S. patent application Ser. No. 12/249,600, filed Oct. 10,2008 and entitled Multi-Language/Multi-Processor Infusion Pump Assembly;U.S. patent application Ser. No. 12/249,540, filed Oct. 10, 2008 andentitled An Infusion Pump Assembly with a Backup Power Supply; and U.S.patent application Ser. No. 12/249,496, filed Oct. 10, 2008 and entitledPump Assembly with a Removable Cover Assembly, all of which are hereinincorporated by reference in their entireties. In the exemplaryembodiment, the infusion pump includes hardware for wireless RFcommunication with a controller. However, in various embodiments, theinfusion pump may be any infusion pump. Referring to FIGS. 1A-1F and2A-2D, in some exemplary embodiments, the infusion pump may include adisplay assembly 104, however, in other exemplary embodiments, such asthose shown in FIGS. 2A-2D, the infusion pump may not include a displayassembly. In these embodiments, a display assembly which may be similarto the one shown in FIGS. 1A, 1D and 1F, or may be larger or smaller, isincluded on a controller or companion device. An embodiment of thecontroller or companion device is shown in FIG. 3.

Referring to FIGS. 1A-1F, an embodiment an infusion pump assembly 100that may be housed within enclosure assembly 102 is shown. Infusion pumpassembly 100 may include a display system 104 that may be visiblethrough the enclosure assembly 102. One or more switch assemblies/inputdevices 106, 108, 110 may be positioned about various portions of theenclosure assembly 102. The enclosure assembly 102 may include infusionport assembly 112 to which cannula assembly 114 may be releasablycoupled. A removable cover assembly 116 may allow access to a powersupply cavity 118 (shown in phantom on FIG. 1D).

Referring to the infusion pump assemblies shown in FIG. 1A-1F, infusionpump assembly 100 may include processing logic (not shown) that executesone or more processes that may be required for infusion pump assembly100 to operate properly. Processing logic may include one or moremicroprocessors (not shown), one or more input/output controllers (notshown), and cache memory devices (not shown). One or more data busesand/or memory buses may be used to interconnect processing logic withone or more subsystems. In some embodiments, at least one of thesubsystems shown in FIG. 4 is also included in the embodiment of theinfusion pump assembly 200 shown in FIGS. 2A-2D.

The various embodiment of the infusion pump shown in FIGS. 2A-2D includethose described in U.S. Pat. No. 5,575,310, issued Nov. 19, 1996 andentitled Flow Control System with Volume-Measuring System Using aResonatable Mass; and U.S. Pat. No. 5,755,683, issued May 26, 1998 andentitled Cassette for Intravenous-Line Flow-Control System both of whichare assigned to DEKA Products Limited Partnership, as well as U.S.Patent Application Publication No. US-2007-0228071, published on Oct. 4,2007 and entitled Fluid Delivery Systems and Methods; U.S. PatentApplication Publication No. US-2007-0219496, published on Sep. 20, 2007and entitled Pumping Fluid Delivery Systems and Methods Using ForceApplication Assembly; U.S. Patent Application Publication No.US-2007-0219480, published on Sep. 20, 2007 and entitled Patch-SizedFluid Delivery Systems and Methods; U.S. Patent Application PublicationNo. US-2007-0219597, published on Sep. 20, 2007 and entitled Adhesiveand Peripheral Systems and Methods for Medical Devices; and U.S. patentapplication Ser. No. 12/347,985, filed Dec. 31, 2008 and entitledInfusion Pump Assembly.

Referring to FIGS. 2A-2D, infusion pump assembly 200 may include areusable housing assembly 202. Reusable housing assembly 204 may beconstructed from any suitable material, such as a hard or rigid plastic,that will resist compression. For example, use of durable materials andparts may improve quality and reduce costs by providing a reusableportion that lasts longer and is more durable, providing greaterprotection to components disposed therein.

Reusable housing assembly 204 may include a mechanical control assembly(not shown) having a pump assembly and at least one valve assembly. Thereusable housing assembly 204 may also include an electrical controlassembly configured to provide one or more control signals to themechanical control assembly and effectuate the basal and/or bolusdelivery of an infusible fluid to a user. Disposable housing assembly202 may include at least one valve assembly which may be configured tocontrol the flow of the infusible fluid through a fluid path. Reusablehousing assembly 204 may also include a pump assembly which may beconfigured to pump the infusible fluid from the fluid path to the user.

An electrical control assembly may be housed in the reusable housingassembly 204 and may monitor and control the amount of infusible fluidthat has been and/or is being pumped. For example, electrical controlassembly may receive signals from a volume sensor assembly and calculatethe amount of infusible fluid that has just been dispensed anddetermine, based upon the dosage required by the user, whether enoughinfusible fluid has been dispensed. If enough infusible fluid has notbeen dispensed, electrical control assembly may determine that moreinfusible fluid should be pumped. Electrical control assembly mayprovide the appropriate signal to mechanical control assembly so thatany additional necessary dosage may be pumped or electrical controlassembly may provide the appropriate signal to mechanical controlassembly so that the additional dosage may be dispensed with the nextdosage. Alternatively, if too much infusible fluid has been dispensed,electrical control assembly may provide the appropriate signal tomechanical control assembly so that less infusible fluid may bedispensed in the next dosage.

The mechanical control assembly may include at least one shape-memoryactuator. The pump assembly and/or valve assembly of the mechanicalcontrol assembly may be actuated by at least one shape-memory actuator,e.g., shape-memory actuator, which may be a shape-memory wire in wire orspring configuration. Shape memory actuator may be operably connected toand activated by an electrical control assembly, which may control thetiming and the amount of heat and/or electrical energy used to actuatemechanical control assembly. Shape memory actuator may be, for example,a conductive shape-memory alloy wire that changes shape withtemperature. The temperature of shape-memory actuator may be changedwith a heater, or more conveniently, by application of electricalenergy. Shape memory actuator may be a shape memory wire constructed ofnickel/titanium alloy, such as NITINOL™ or FLEXINOL®.

Infusion pump assembly 200 may include a volume sensor assemblyconfigured to monitor the amount of fluid infused by infusion pumpassembly. For example, the volume sensor assembly may employ, forexample, acoustic volume sensing using acoustic volume measurementtechnology, including, but not limited to, technologies described in thefollowing references: U.S. Pat. Nos. 5,575,310 and 5,755,683 assigned toDEKA Products Limited Partnership, as well as U.S. patent applicationPublication Nos. US 2007/0228071 A1, US 2007/0219496 A1, US 2007/0219480A1, US 2007/0219597 A1, all of which are incorporated herein byreference in their entirety. Other alternative techniques for measuringfluid flow may also be used; for example, Doppler-based methods; the useof Hall-effect sensors in combination with a vane or flapper valve; theuse of a strain beam (for example, related to a flexible member over afluid reservoir to sense deflection of the flexible member); the use ofcapacitive sensing with plates; or thermal time of flight methods. Onesuch alternative technique is disclosed in U.S. Publication No.US-2007-0228071, published on Oct. 4, 2007 entitled Fluid DeliverySystems and Methods, of which is incorporated herein by reference in itsentirety. Infusion pump assembly 200 may be configured so that thevolume measurements produced by the volume sensor assembly may be usedto control, through a feedback loop, the amount of infusible fluid thatis infused into the user.

Infusion pump assembly 200 may further include a disposable housingassembly 202. For example, disposable housing assembly 202 may beconfigured for a single use or for use for a specified period of time,e.g., three days or any other amount of time. Disposable housingassembly 202 may be configured such that any components in infusion pumpassembly 200 that come in contact with the infusible fluid are disposedon and/or within disposable housing assembly 202. For example, a fluidpath or channel including a reservoir, may be positioned withindisposable housing assembly 202 and may be configured for a single useor for a specified number of uses before disposal. The disposable natureof disposable housing assembly 202 may improve sanitation of infusionpump assembly 200.

The disposable housing assembly 202 may be configured to releasablyengage reusable housing assembly 204, and includes a cavity that has areservoir for receiving an infusible fluid (not shown), e.g., insulin.Such releasable engagement may be accomplished by a screw-on, atwist-lock or a compression fit configuration, for example. Disposablehousing assembly 202 and/or reusable housing assembly 204 may include analignment assembly configured to assist in aligning disposable housingassembly 202 and reusable housing assembly 204 for engagement in aspecific orientation. Similarly, base nub 206 and top nub 208 may beused as indicators of alignment and complete engagement.

Referring now to FIGS. 2A-2B, in this particular embodiment of theinfusion pump assembly 200, infusion pump assembly 200 may includeswitch assembly 210 positioned about the periphery of infusion pumpassembly 200. In other embodiments, for example, those shown in FIGS.2C-2D, the switch assembly 216 may be positioned elsewhere on thereusable housing assembly 204, including but not limited to, on the topsurface. Referring back to FIGS. 2A-2B, in the exemplary embodimentshown, switch assembly 210 may be positioned along a radial edge ofinfusion pump assembly 200, which may allow for easier use by a user.Switch assembly 210 may be covered with a waterproof membrane configuredto prevent the infiltration of water into infusion pump assembly 200.Reusable housing assembly 204 may include main body portion (housing theabove-described mechanical and electrical control assemblies) andlocking ring assembly 212 that may be configured to rotate about mainbody portion (in the direction of arrow 214).

In a fashion similar to reusable housing assembly 204 and disposablehousing assembly 202, reusable housing assembly 204 may be configured toreleasably engage disposable housing assembly 202. Such releasableengagement may be accomplished by a screw-on, a twist-lock or acompression fit configuration, for example. In an embodiment in which atwist-lock configuration is utilized, the user of infusion pump assembly200 may first properly position reusable housing assembly 204 withrespect to disposable housing assembly 202 and may then rotate lockingring assembly 212 (in the direction of arrow 214) to releasably engagereusable housing assembly 204 with disposable housing assembly 202.

Through the use of locking ring assembly 212, reusable housing assembly204 may be properly positioned with respect to disposable housingassembly 202 and then releasably engaged by rotating locking ringassembly 212, thus eliminating the need to rotate reusable housingassembly 204 with respect to disposable housing assembly 202.Accordingly, reusable housing assembly 204 may be properly aligned withdisposable housing assembly 202 prior to engagement, and such alignmentmay not be disturbed during the engagement process. Locking ringassembly 212 may include a latching mechanism (not shown) that mayprevent the rotation of locking ring assembly 212 until reusable housingassembly 204 and disposable housing assembly 202 are properly positionedwith respect to each other.

Referring now to FIGS. 1A-1F and FIG. 4, examples of the subsystemsinterconnected with processing logic 400 may include but are not limitedto memory system 402, input system 404, display system 406, vibrationsystem 408, audio system 410 motor assembly 416, force sensor 412,temperature sensor (not shown) and displacement detection device 418.Infusion pump assembly 100 may include primary power supply 420 (e.g. abattery) configured to be removable installable within power supplycavity 118 and to provide electrical power to at least a portion ofprocessing logic 400 and one or more of the subsystems (e.g., memorysystem 402, input system 404, display system 406, vibration system 408,audio system 410, motor assembly 416, force sensor 412, and displacementdetection device 418).

Infusion pump assembly 100 may include reservoir assembly 430 configuredto contain infusible fluid 422. In some embodiments, reservoir assembly430 may be a reservoir assembly similar to that described in U.S. Pat.No. 7,498,563, issued Mar. 3, 2009 and entitled Optical DisplacementSensor for Infusion Devices, which is herein incorporated by referencein its entirety, and/or as described in U.S. Pat. No. 7,306,578, issuedDec. 11, 2007 and entitled Loading Mechanism for Infusion Pump; U.S.patent application Ser. No. 12/249,882, filed Oct. 10, 2008 and entitledInfusion Pump Assembly; and U.S. patent application Ser. No. 12/249,891,filed Oct. 10, 2008 and entitled Infusion Pump Assembly all of which areherein incorporated by reference in their entireties. In otherembodiments, the reservoir assembly may be any assembly in which fluidmay be acted upon such that at least a portion of the fluid may flow outof the reservoir assembly, for example, the reservoir assembly, invarious embodiments, may include but is not limited to: a barrel with aplunger, a cassette or a container at least partially constructed of aflexible membrane.

Plunger assembly 424 may be configured to displace infusible fluid 422from reservoir assembly 430 through cannula assembly 450 (which may becoupled to infusion pump assembly 100 via infusion port assembly 424) sothat infusible fluid 422 may be delivered to user 454. In thisparticular embodiment, plunger assembly 424 is shown to be displaceableby partial nut assembly 426, which may engage lead screw assembly 428that may be rotatable by motor assembly 416 in response to signalsreceived from processing logic 400. In this particular embodiment, thecombination of motor assembly 416, plunger assembly 424, partial nutassembly 426, and lead screw assembly 428 may form a pump assembly thateffectuates the dispensing of infusible fluid 422 contained withinreservoir assembly 430. An example of partial nut assembly 426 mayinclude but is not limited to a nut assembly that is configured to wraparound lead screw assembly 426 by e.g., 30 degrees. In some embodiments,the pump assembly may be similar to one described in U.S. Pat. No.7,306,578, issued Dec. 11, 2007 and entitled Loading Mechanism forInfusion Pump; U.S. patent application Ser. No. 12/249,882, filed Oct.10, 2008 and entitled Infusion Pump Assembly; and U.S. patentapplication Ser. No. 12/249,891, filed Oct. 10, 2008 and entitledInfusion Pump Assembly all of which are herein incorporated by referencein their entireties.

User Interface

Throughout this description, screens may be referenced with respect tothe “pump” or “Companion” or “Controller”. However, in variousembodiments, a similar screen or a similar method may be accomplished onanother device. For example, where the screen or method is referencedwith respect to the “pump”, a similarly functional screen or method maybe used on the “Companion” in other embodiments. As this descriptionincludes embodiments related to both pumps having displays and pumpshaving no displays, it should be evident that where the embodimentincludes an infusion pump without a display, any screens will be visibleon a Companion. Similarly, where a method requires an interactionbetween the user and the pump, the interaction may be accomplished via aswitch assembly on the pump where the pump is an infusion pump without adisplay.

Processing logic which in some embodiments, includes at least oneelement as shown in described with respect to FIG. 4, is used to receiveinputs from a user or caregiver. The user or caregiver uses one or moreinput devices or assemblies, including but not limited to, one or moreof the following: button/switch assembly, slider (for example, includingbut not limited to any slider described in U.S. Publication No.US-2008-0177900, published Jul. 24, 2008 and entitled Medical DeviceIncluding a Slider Assembly, which is herein incorporated by referencein its entirety), jog wheel or touch screen. The infusion deviceadditionally received inputs from internal systems, including but notlimited to occlusion detection process 438, confirmation process 440,volume measurement technology (e.g., acoustic volume sensing). Usingthese inputs, the infusion device produces outputs, for exampleincluding, but not limited to, infusion fluid delivery to the user orcomments, alerts, alarms or warnings to the user. The inputs are thuseither directly from the user to the pump, directly from the pumpsystems to the processing logic, or from another device, e.g., a remotecontroller device (described in more detail below), to the pump. Theuser or caregiver interaction experience thus includes, but is notlimited to, one or more of the following: interaction with a display(either on the infusion pump device itself or a remote controller deviceor both), which includes but is not limited to, reading/seeing textand/or graphics on a display, direct interaction with a display, forexample, through a touch screen, interaction with one or more buttons,sliders, jog wheels, one or more glucose strip readers, and sensingeither through touch sensation or audio, one or more vibration motors,and/or an audio system. Thus, the term “user interface” is used toencompass all of the systems and methods a user or caregiver interactswith the infusion pump, to control the infusion pump.

Referring now to FIG. 3, in some embodiments of the infusion pumpsystem, the infusion pump may be remotely controlled using a remotecontroller assembly 300, also referred to as a controller or acompanion. Remote control assembly 300 may include all, or a portion of,the functionality of the infusion pump assembly shown in FIGS. 1A-1F,itself. Thus, in some exemplary embodiments of the above-describedinfusion pump assembly, the infusion pump assembly (not shown, see FIGS.1A-1F, amongst other FIGS.) may be configured via remote controlassembly 300. In these particular embodiments, the infusion pumpassembly may include telemetry circuitry (not shown) that allows forcommunication (e.g., wired or wireless) between the infusion pumpassembly and e.g., remote control assembly 300, thus allowing remotecontrol assembly 300 to remotely control infusion pump assembly 100.Remote control assembly 300 (which may also include telemetry circuitry(not shown) and may be capable of communicating with infusion pumpassembly) may include display assembly 302 and an input assembly, whichmay include one or more of the following: an input control device (suchas jog wheel 306, slider assembly 310, or another conventional mode forinput into a device), and switch assemblies 304, 308. Thus, althoughremote control assembly 300 as shown in FIG. 3 includes jog wheel 306and slider assembly 310, some embodiments may include only one of eitherjog wheel 306 or slider assembly 310, or another conventional mode forinput into a device. In embodiments having jog wheel 306, jog wheel 306may include a wheel, ring, knob, or the like, that may be coupled to arotary encoder, or other rotary transducer, for providing a controlsignal based upon, at least in part, movement of the wheel, ring, knob,or the like.

Remote control assembly 300 may include the ability to pre-program basalrates, bolus alarms, delivery limitations, and allow the user to viewhistory and to establish user preferences. Remote control assembly 300may also include a glucose strip reader 312.

During use, remote control assembly 300 may provide instructions to theinfusion pump assembly via a wireless communication channel establishedbetween remote control assembly 300 and the infusion pump assembly.Accordingly, the user may use remote control assembly 300 toprogram/configure the infusion pump assembly. Some or all of thecommunication between remote control assembly 300 and the infusion pumpassembly may be encrypted to provide an enhanced level of security.

In the exemplary embodiments of the user interface, the user interfacerequires user confirmation and user input. The exemplary embodiments ofthe user interface are centered on ensuring the user knows the effect ofvarious interactions on the pump. Many examples will be presentedthroughout this description of the pump communicating the result of theuser's actions to the user. These features ensure the user understandstheir actions and therefore, imparts greater safety onto the user. Onesuch example is throughout the exemplary embodiment of the userinterface, where the user presses the back button on a screen after avalue has been changed, the user interface displays the Cancel Changesconfirmation screen, as shown in FIG. 6. If the user selects “Yes”, theuser interface discards any pending changes, closes the confirmationscreen and goes back to the previous screen (i.e., the screen previousto the screen where the user pressed the Back button). When the actionselection is “No”, on the “Cancel Changes?” confirmation screen, theuser presses the enter button or other depending on the embodiment, andthe user interface closes the confirmation screen and returns to thescreen with pending changes.

This feature prevents the outcome where the user assumes the changeshave been implemented, but in fact, they have not been. Thus, thisfeature prevents that circumstance and ensures the user understands thatthe changes have not been implemented.

Power Up

Generally, an infusion pump is used for therapy by a user almostcontinuously, with some exceptions. Thus, from the time an infusion pumpis “powered up”, i.e., a battery is inserted into the pump and the pumpis “Setup” for use for therapy, the infusion pump remains on and in manycases, connected to the user by way of a cannula. Oftentimes, a userwill “disconnect”, i.e., disrupt the fluid connection of the tubing tothe cannula, for short and predicted periods of time. For example, usersoften disconnect while changing the cannula, changing the infusion set,changing the reservoir, priming the tubing, bathing/showering,undergoing tests such as an MRI, or otherwise being exposed to harmfulforces, for example, electromagnetic forces, or, in some circumstances,while exercising or being exposed to potentially corrosive water, forexample, salt water. There are many additional circumstances where usersmay disconnect. However, generally, these disconnection events areplanned and the user understands they will not receive therapy from theinfusion pump while disconnected from the pump.

Thus, once infusion pump therapy has begun with a given pump, the userwill remain connected and will likely receive their therapy from theinfusion pump until and unless the infusion pump is replaced by anotherform of therapy, for example, another pump or multiple daily injections.

The power up user interface is visible when a battery is inserted intothe infusion pump. If the infusion pump has been in use by the userprior to the battery change, then the pump will initialize. If the pumphad not been previously used by the user (i.e., the pump is new to theuser), on first use of the pump, the user interface automatically guidesthe user through programmable settings that must be initialized beforeinsulin delivery or other fluid therapeutic delivery may occur.

Referring now to FIG. 5A, after the initialization period, the userinterface advances to Time and Date Wizard, which takes the user throughthe TIME/DATE, SET TIME and SET DATE screens, and then advances to theHome screen (as also discussed with respect to FIGS. 10A-10E). As shownin FIG. 5A, if a valid time is detected, the default selection for theuser is “next” on the TIME/DATE screen 500, wherein the user interfaceproceeds to an initializing screen 502 then to the Home Screen 504.

However, referring now to FIGS. 5B-5C, if the system does not detect avalid time and date, the Time and Date Wizard shall display theTIME/DATE screen with the Time values set to dashes (--) to indicatethat no values are currently set. The Date value is not displayed untila valid time has been set.

Amongst other advantages, where the system detects a valid TIME/DATE,the Time and Date Wizard automatically fills the TIME/DATE with thedetected valid TIME/DATE. However, the system still ensures that theuser reviews the detected TIME/DATE and presents an opportunity for theuser to change the TIME/DATE if the TIME/DATE on the screen isincorrect. In fact, in the exemplary embodiment shown, the system willnot complete initializing and will not advance to the Home Screen untilthe user has selected “next”, i.e., affirming the TIME/DATE isacceptable.

Conversely, where an invalid date is detected, the system does notautomatically fill the TIME/DATE but rather requires the user to do so.Thus, the user interface system, in the exemplary embodiment, requiresthe user to always review the TIME/DATE.

Some embodiments of the user interface include a Trainer Mode. This modeis generally used when a user or caregiver is initially using the pumpand thus may take additional time to review and enter information intothe user interface. The Trainer Mode allows for the user to select aduration that the user interface will disable timeouts. In normal mode,the user interface otherwise includes timeouts as a power conservationmeasure, where the screen will timeout at a preset interval of userinactivity. However, in this embodiment, the timeouts are disabled. Inthe exemplary embodiment, when the Trainer Mode is initialized, a“duration” is set by the user or caregiver, for example, 2 hours, andduring this duration, timeouts are disabled.

User Setup

User Setup includes many features to the user and those used by the pumpfor therapy. These include but are not limited to setting the: pairingwith a companion, time, date, time/date format, time format, glucoseunits (mg/dL vs. mmol/L), language, blood glucose targets by time ofday, basal rate by time of day or preprogrammed title, insulin type,duration of action of insulin, cursor preference, magnify preference,bolus button, bolus and basal limits, “1 U Drop” (one unit drop),display/button side, carbohydrate to insulin ratio, alarm featuresincluding alarm types where options exist, sensitivity to occlusion,inactivity alarm, therapy lockouts, care comments and reminders.

As discussed above, in the exemplary embodiments, the infusion pumpsystem includes a controller or companion device, for example, similarto one described above. In these embodiments, at Power Up, if the pumpis not currently paired and not fully initialized the user is firstprompted to pair the pump with a remote control device, i.e., acontroller or Companion, as discussed above. The user may choose to skipthis option, for example, where the user does not desire to pair with acompanion device. In this case, the user interface advances the user toother Setup screens.

Referring to FIG. 7A, if the user chooses to initiate the pairing (byselecting OK); the user interface displays the PUMP Searching forCompanions screen (it should be noted that where the pump is anembodiment that does not include a display, the Companion will be theonly screens during the pairing process. Thus, similar screens willappear on the Companion only). The remote Companion must be in pairingmode for the pairing to be completed. Thus, for pairing an infusion pumpwith a Companion, both devices must be in pairing mode. This featureserves as one of many safety features during the pairing process.Requiring both devices to be in pairing mode ensures an infusion pump isnot “hijacked” by a non-intended Companion. If the pairing fails or iscancelled, when the user selects OK on the Pairing Failed or PairingCancelled warning screen, the user interface displaces the STEP 1 screenon the Setup Wizard and sets the Radio setting to “Off”. Thus, where thesystem is not paired, the pump user interface automatically turns theradio off and proceeds to continue Setup Wizard.

Referring now to FIG. 7B, to pair a pump and Companion device for remotecommunications, the pairing process requires user interaction on boththe pump and Companion. In the exemplary embodiment, the user interfacedisplays the PUMP “Searching for Companions” screen on the pump when theuser selects and accepts the “PAIR DEVICE” item on the “SETUP” screen.The user selects the “PAIR DEVICE” item to initiate the pairing processwith and begin searching for a remote control Companion device inpairing mode. On the Companion, the user selects “PAIR PUMP” on the“SETUP” screen, then selects the “Yes” action selection on the “Is pumpready?” confirmation screen. Before selecting “Yes”, the user needs tostart the search on the pump. Thus, in pairing mode, both the infusionpump and the Companion must be in pairing mode, simultaneously, for thepairing mode to commence.

When the user selects the “PAIR DEVICE” item on the pump “SETUP” screenand presses the enter button, the user interface: 1) turns on the radioif it is turned off; 2) initiates a search for Companion devices thatare in pairing mode (where pairing has been initiated on the Companion);and 3) displays the “Searching for Companions” pairing screen.

Referring now to FIG. 7C, the user interface displays the PUMP “FoundCompanion “{Companion Serial #}” screen on the pump following the PUMP“Searching for Companions” screen, when a Companion in pairing mode hasbeen found. The serial number of the Companion is displayed on thescreen in place of the “{Companion Serial #}”. This screen indicates aCompanion in pairing mode has been found, but the pairing has not beencompleted. The user must confirm the pairing on the Companion device forthe pairing process to be complete. This feature ensures the user has anopportunity to confirm that the pump found is indeed the pump in whichthe user intends to pair with the Companion device.

The user interface displays “No Companions Found” warning screen on thepump when the user initiated pairing, and the search for Companions inpairing mode failed after searching for approximately 1 minute. In otherembodiments, the amount of searching time may vary. The pump userinterface, in the exemplary embodiment, turns off the radio and warnsthe user when no Companions were found after searching for Companionsfor a defined time period without button press interruptions (See FIG.7D). This ensures that where pairing mode has commenced on one side, forexample, on the Companion but not the pump, a timeout period will endthe pairing mode.

Referring to FIG. 7E, the user interface displays the PUMP “Paired with{Companion Serial #}” screen on the pump when the pairing has beenconfirmed on the Companion device. In the exemplary embodiment, the userinterface displays an indication to the user of the Companion deviceserial number to which a pump is paired when a pump and Companion havebeen successfully paired. This feature allows the user opportunity toconfirm the Companion serial number indicates the intended Companion ispaired with the pump.

Once the “Done” is selected, where the pump is fully initialized, thepump will proceed to the Home screen. Where the pump is not fullyinitialized, the user interface will display the Setup Wizard Step 1screen.

Although the above embodiments are described with reference to the PUMPscreens, similar screens are displayed on the Companion throughout thepairing process.

During pairing, the user interface displays the “Pairing cancelled”warning screen on either the pump or the Companion device, when the userpresses a button on the pump while displaying the PUMP “Searching forCompanion” screen, or on the Companion while displaying the COMPANION“Searching for Pumps” screen. If the pump or Companion were pairedbefore attempting to pair them again, and the user cancelled thepairing, the existing pairing is not lost.

Pairing may be cancelled where the user presses a button on the pump orthe Companion while the “Searching for . . . ” screen is displayed.Referring now to FIG. 7F, the user interface displays an indication tothe user that the pairing process was cancelled before the pump andCompanion were successfully pairing. Thus, the user will be aware thatthe pump and Companion may not be paired (in the exemplary embodiment,if the pump and Companion were paired, a screen or audio signal willindicate same).

In the exemplary embodiment, the user interface displays the“Incompatible pump found. Pairing failed” WARNING screen on theCompanion during the pairing process, when a pump in pairing mode isfound that has a serial number that indicates different glucose unitsthan the units configured on the Companion (i.e., mg/dL vs. mmol/L). Asa safety feature, the user interface considers a pump and Companion withdifferent glucose units incompatible and disallows pairing the twodevices. When the user attempts to pair the pump and Companion withdifferent glucose units, any previous pairing is lost.

Either after pairing is completed or once pairing has been skipped, theuser completes the “Setup Wizard”, setting various features of the userinterface.

As discussed above with respect to FIGS. 5B-5C, because the infusionpump delivers insulin (or another fluid) based on time of day (in theexemplary embodiment, however, in other embodiments, the pump maydeliver based on another criteria, for example, every “2 hours”, or“once daily”), it is important that the time settings are accurate.Also, in the exemplary embodiment, the pump device logs a history ofinsulin (or other fluid) delivery. Therefore, it is important that thedate settings are accurate. When the user first initializes the pump, orwhen the system does not detect a valid time, the Current Time settingshave no default values, and the user interface requires the user to setthe current time. Additionally, when the user changes the battery in thepump, the user interface requires the user to review the settings forthe current time to ensure that they are accurate.

After the user has set a valid time, the time is continuously updated bythe device's real-time clock. After the device has fully initialized,the user may change the current time by entering either the Setup Wizardor the Time and Date Wizard through the SETUP screen.

If the user changes the time and/or date on the pump and then accessesthe user interface on the Companion device, the time and date on theCompanion is synchronized with the pump's time and date, and a warningscreen is displayed on the Companion to indicate the time on theCompanion has been changed to the pump time.

When the user first initializes the pump, or when the system does notdetect a valid date, the Current Date settings have no default values,and the user interface requires the user to set the current date.Additionally, when the user changes the battery in the pump, the userinterface requires the user to review the settings for the current dateto ensure that they are accurate.

After the user has set a legal date value, the date is maintained andupdated by the pump's real-time clock. If the user enters a non-legaldate, then the pump will indicate same with an audio and/or visualindication that the date is not accepted. After the device has fullyinitialized, the user may change the current date by entering either theSetup Wizard or the Time and Date Wizard through the SETUP screen.

The user interface includes a preprogrammed list of “legal dates”. Thesemay be based on the Gregorian calendar, or within any otherpre-definable parameters. These may include, for example, but notlimited to, the number of days for particular months, the years in whicha date of February 29 is a legal date. In the exemplary embodiment, theuser interface may only allow these parameters to be changed at a systemlevel, i.e., not by the user. However, in other embodiments, the userinterface may allow the user to change the parameters.

In the exemplary embodiment of the pump, as discussed above, the pump isan insulin pump. The insulin concentration value (Units/mL) ispreprogrammed to be “U100” and cannot be changed by the user. This is asafety measure, as generally, a user on insulin therapy uses U100insulin. However, in various embodiments where either a differentinsulin therapy is contemplated, or, if a different fluid is infused,this feature may require user input to specify the concentration of thefluid.

Related settings that the user may specify include the insulin type andaction time. The user interface uses these settings to determine theamount of Insulin on Board or “IOB”. IOB refers to a number which servesas a gauge to the “action” of the insulin currently in the user. Thegauge is comparing the action available to a quantitative “amount ofinsulin” currently in the user. Thus, as the Action Time and InsulinType are used to calculate IOB, which is used, as described later, inbolus calculations, it is critical this information be entered.

When the pump is fully initialized, the user may change the insulinsettings by entering the Setup Wizard through the SETUP screen, or byselecting INSULIN on the SETUP screen. Referring to FIG. 8A, theexemplary embodiment of these screens are shown.

Referring now to FIG. 8B, the user interface opens the SET TYPE edititem screen when the user accepts the Type item on the Insulin Profileselect item for edit screen, and Magnify is set to On. “Magnify” refersto an option in the exemplary embodiment of the user interface, wherethe user may prefer that the text in the curser and in various screens,be “magnified” so as to be better visible. Various embodiments of thisfeature may be used in the user interface, including those described inpending U.S. Publication No. US-2008-0177900, published Jul. 24, 2008and entitled Medical Device Including a Slider Assembly, which is hereinincorporated by reference in its entirety.

When Magnify is “Off”, or when the user accesses the screen on theCompanion device, the user interface opens the Type item for editing.The Type value identifies the type of insulin being used. Two optionsare available in the exemplary embodiment, either Rapid or Short. Invarious other embodiments, additional options may be pre-programmableand selectable options.

The exemplary embodiment of the user interface includes various safetyfeatures related to the INSULIN PROFILE screens. For example, when theType item on the INSULIN PROFILE screen is open for editing and the userpresses a soft-key button for “Next” or “Done” action selection, theuser interface will either: 1) accept and close the selected value; orif the user changed the Type value, the user interface will change theAction Time value to dashes and display a warning message in languagedependant text: “Dashed items must be set”. This is to prompt the userthat an Action Value must be entered; or, 3) if the user did not changethe Type value, select the action selection, save any pending changesand advance to the next screen.

Referring to FIGS. 9A-9B, in the exemplary embodiment of the userinterface, the user may configure display settings for the pump to havethe user interface screens oriented such that the enter and backbuttons, for example, are either on the right side of the LCD display,or the left side. Additionally, the device uses screen timeouts toconserve energy by turning off the display and entering into a low-powersleep state when the user has stopped interacting with the device withina period of time. The user configures this timeout value as part of thedisplay settings. Screen timeouts are not in effect until after the pumpis fully initialized.

Another display setting that the user may configure is the whether todisplay an activity-based home screen or an information-based homescreen. The Home screen is further described below with reference toFIGS. 10A-10E. In the exemplary embodiment, the user interface allowsthe user to access the display settings for the pump through the SetupWizard STEP 2 screen, by advancing the DISPLAY screen. The displaysettings that also apply to the Companion are accessible on theCompanion by selecting REFERENCES on the SETUP screen.

Referring to FIG. 9A, the user interface allows the user to set aduration value for the timeout feature of the display. Additionally, theuser may select the home screen feature using the DISPLAY screens.

Referring now to FIG. 9B, the user interface includes a feature whichallows the user to configure the display orientation of the userinterface screen on the pump as it relates to the position of thebuttons (i.e., referring to FIG. 1A, the switch assemblies 108). Forexample, the user interface allows the user to designate whether thebuttons are on the left of the display, or the right. In the exemplaryembodiment, the user interface may have a default setting, for example,buttons on right or buttons on left.

Referring now to FIG. 9A, the user interface opens the SET BUTTONS edititem screen when the user accepts the Buttons item on the DISPLAY selectitem for edit screen, and the user-programmable settings for Magnify isset to “On”. When Magnify is “Off”, or when the user accesses the screenon the Companion device, in the exemplary embodiment, the user interfaceopens the Buttons item for editing. The user accept the Buttons item toconfigure the device to orient the user interface screens such that thebuttons are either on the right of the LCD display, or on the left. Anexemplary embodiment of the BUTTON screens are shown in FIG. 9B.

The ability of the user to set the side of the buttons allows the userto customize the pump to their preferred hand. Thus, this is anadvantage for ease of use to the user. Additionally, in some embodimentsof the infusion pump, as shown in FIGS. 1A-1F, where a slider 106 may beused as input device, the ability of the user to set the user interfacesuch that they are free to use their preferred hand in all inputs is anadvantage and may allow the user to be more efficient and safe in thehandling of inputs to the pump.

In the exemplary embodiment, the user interface includes a boluscalculator. The user must provide particular input information regardingtheir therapy into the user interface while using the bolus calculatoroption. However, in some cases, the user may choose to enter thisinformation in advance through Setup screens. The information entered inadvance may then be used in any calculators requiring this information.However, the information may be entered at the time of the use of thecalculator.

The information used by the calculator is typically based on a user'smedical team's recommendation. The bolus calculator requires thisinformation. In addition to the INSULIN screens discussed above, theuser may also enter information regarding “1U DROP”, carbohydrate ratiosand Blood Glucose targets.

Referring now to FIGS. 11A-11B, various 1U DROP screens are shownaccording to an exemplary embodiment. In the exemplary embodiment, theuser may set from 1 to 24 1U DROP values based on the time of day. Inaddition, the user may set from 1 to 24 insulin to carbohydrate ratios(i.e., I:CHO) based on the time of day. However, in various otherembodiments, the user may set more than 24 1U DROP values (and/or I:CHOvalues), and may also specify the day of the month or the day of theweek, amongst many additional factors that may be specified. The 1U DROPvalues are known insulin sensitivity values (i.e., how much insulincauses how much change) for the user. The I:CHO value defines thedefault ratio of carbohydrate grams to 1 Unit of insulin for a specifiedtime period. The 1U DROP value is used to calculate how much insulin thepump may recommend the user deliver to bring the user's blood glucosevalue to a desired level. The 1U DROP values may be programmed on thehour. In some instances, the 1U DROP value may not have been previouslyset by the user. In these cases, while using the bolus calculatoroption, the user may specify the 1U DROP value when programming acorrection bolus.

In the exemplary embodiment, and as may be seen in FIGS. 11A-11B, theuser interface may allow the user to program 1 to 24 correction factorvalues, based on the time of day, that estimates how much change to auser's blood glucose level is effected by 1 unit of insulin.

The I:CHO value may be used in bolus calculations where the user entersan amount of carbohydrates and the bolus calculator suggests an insulindosage. Further, the I:CHO may be used during a correction and foodbolus calculation.

In the exemplary embodiment of the user interface, the user interfaceallows the user to define the Increment of insulin Units that will beused for each click of the slider when delivering either a normal bolusor an extended bolus through the user interface bolus screens.Additionally, in the exemplary embodiment, the user interface allows theuser to define the Increment of insulin Units that will be used for eachclick of the slider when setting or editing a Rate value for a Basalprogram. In various embodiments, in addition to the slider, theIncrement may be used to define the Increment of insulin Units used foreach press of a button or each step movement of a jog wheel, forexample. However, the Increment function may be used in variousembodiments to apply to any input device or assembly desired.

The Increment item allows the user to customize the user interface fortheir general therapy needs. For example, the user interface may allowthe user to select an increment of “0.10U”, “0.05U”, or “1.00U” forexample. Thus, a user having a therapy that typically includes bolus orbasal program amounts of “0.30U” may select the “0.10U” Increment,whereas a user having a therapy that typically includes bolus or basalprogram amounts of “10.0U” may select the “1.00U” Increment. Thus, thisallows for more efficient use by the user in delivering their therapy.

The user interface includes an option for SET TEMP, i.e., setting atemporary basal. In the exemplary embodiment, the SET TEMP optionincludes the option of the user setting or configuring the temporarybasal amount in terms of delivery rate (i.e., Units/hour), or in termsof a percentage of the active basal program rate. Thus, in the exemplaryembodiment a user may define the temporary basal rate or may request atemporary basal reduction, based on the current basal program.

Referring now to FIG. 12, the user interface additionally includes, inthe exemplary embodiment, a LOCKED ITEMS settings feature which allowsthe user to lock or unlock certain features of the device to restrictaccess to those features. These features include, but may not be limitedto:

-   -   1) the basal menu features that allow the user to activate an        existing basal program, start temporary bases, edit, delete or        rename an existing basal program;    -   2) the bolus features that allow the user to deliver one-button,        normal, extended, and dual boluses;    -   3) the prime feature allowing the user to prime the pump.

Thus, in the exemplary embodiment, the user interface allows flexibilityby allowing the user to lockout features separately, rather than eitherlocking the whole pump, or unlocking the whole pump. This feature may beadvantageous with respect to child users or other users that may not becapable of making therapy decision, but may, when necessary, need accessto priming or basal changes.

In the exemplary embodiment, the user interface includes variousfeatures that inform the user when various screens are exited orinformation is missing. These features ensure the user knows the impactof their actions. For example, referring now to FIG. 13A, in theexemplary embodiment, when initializing the device settings, the usermust set values for any default settings that have no initial value,i.e., in the exemplary embodiment, those settings displayed as dashes,before advancing to the next screen. The user interface displays theWarning screen “Dashed items must be set” when the user fails tocomplete these settings. In particular, in the exemplary embodiment,this Warning screen will appear where the user:

-   -   1) when initializing device setting values through the Setup        Wizard and the user presses the back button the STEP 1 screen;    -   2) when programming a temporary basal or a bolus, when any items        are set to dashes on the screen and the user accepts the        “Activate” or “Deliver” action selection;    -   3) when initializing device setting values in the Setup Wizard        for the following when the user accepts the “Next”, “Accept” or        “Done” action selection:        -   The TIME/DATE screen when either a time or date has not been            set.        -   The CURRENT TIME screen when all fields of the time value            have not been set.        -   The CURRENT DATE screen when all fields of the date value            have not been set.        -   The INSULIN PROFILE screen when a value has not been set for            the Time item.        -   The CARB RATIOS BLOCK n screen when a value has not been set            for one or more items.        -   The 1U DROP BLOCK n screen when a value has not been set for            one or more items.        -   The BG TARGET BLOCK n screen when a value has not been set            for one or more items.        -   The DAILY basal program BLOCK n screen when a value has not            been set for one or more items.

Referring now to FIG. 13B, while the device is in a delivery mode, theuser interface, in the exemplary embodiment, prevents the user fromchanging certain settings. For example, when the user selects andaccepts the BASAL LIMITS or WIZARD item on the SETUP screen, if thebasal is currently running, the user interface displays the warning“Stop delivery before using this function”. Additionally, when the userselects either the Time or the Date values on the TIME/DATE screen whenbasal delivery is in progress, the user interface will display thisWarning. This is a safety feature in the exemplary embodiment of theuser interface. Where a user change or edit may cause confusion duringdelivery, for example, a rate change of a basal profile while that basalprofile is delivering, or changing the TIME/DATE while in delivery, theuser interface may use the Warning screen shown in FIG. 13B. In theexemplary embodiments, additional features may not be changed duringdelivery. These include but are not limited to lockout features.

Referring now to FIG. 14A, in embodiments where a pump and Companion arepaired, there are various changes that, made on the Companion, may notbe accepted by the pump. For example, when the user sets the time anddate through the Companion-specific time/date screen, if the Companionis paired with the pump and the pump is delivering basal, in theexemplary embodiment, the pump cannot accept a new time, and theCompanion displays the warning “Time and date cannot be saved on pump”.Once the pump and Companion are communicating, upon backgroundsynchronization, the pump time will be sent to the Companion, and theCompanion will display the warning “Companion time changed to pumptime”. This warning screen may be used in many different like scenariosto inform the user both that their requested changes have not been made,and when the change has been made. Thus, the user is informed of theoutcome of their actions and thus is regularly aware of the impact onthe pump.

Referring now to FIG. 14B, in the exemplary embodiment, the userinterface may display a warning on the Companion when the user exits theCompanion PREFERENCES screen, and the pump is either busy orcommunication with the pump is down. Thus, the user is aware that theirpreferences have not been saved onto the pump, and thus, knows that theyshould re-enter those preferences at a time when communications arerestored.

Referring now to FIG. 15, in the exemplary embodiment, the Companion maybe configured to enable a temporary lockout from certain functions, forexample, functions that affect starting and stopping delivery on thepump. However, additional functions may also be locked out temporarilyin some embodiments. The THERAPY LOCKOUT settings screen, shown in FIG.15, allows the user to turn the lockout on, and to specify a durationfor the lockout to be in effect. If the user chooses a duration of“Once”, the lockout is in effect until the user selects Unlock on theTHERAPY LOCKOUT Unlock screen.

Referring now to FIG. 16, the user interface allows a user to turn theradio off when the pump is paired with a Companion. Changing the settingon the pump turns off the radio only on the pump; similarly, changingthe setting on the Companion turns off the radio only on the Companion.This feature allows a user to turn the radio off in cases where radiocommunication when desired, for example, when radio communicationbetween devices is not advisable, allowed or safe.

Home Screen

Referring now to FIGS. 10A-10E, in the exemplary embodiment, the userinterface opens the SET HOME edit item screen when the user accepts theHome item on the DISPLAY select item for edit screen, and theuser-programmable setting for Magnify is set to “On”. When Magnify is“Off”, or when the user accesses the screen on the Companion device, theuser interface opens the Home item for editing. The user accepts theHome item to specify the content of the Home screen as eitherinformation-based or activity-based.

The Home screen provides access to device features and displaysinformation about the status of the pump and the delivery. The Homescreen may be configured to display an activity-based menu (i.e.,Activity-Based home screen), or to display information about the currentdelivery status and last bolus information (i.e., Information-Based Homescreen). The Home screen is configured through the PREFERENCES option onthe SETUP screen.

Still referring to FIGS. 10A-10E, in the exemplary embodiment, for boththe Information-Based and Activity-Based Home screens, the userinterface displays the current time as maintained by the device'sreal-time clock, icons that provide an indication of the remainingbattery capacity and insulin volume (or reservoir volume), and theamount of IOB. In some instances, a greater-than or equal to symbol maybe displayed next to the IOB label. Specifically, if the bolus logcontains a corrupt record, or if the time has been lost and needs to beset at powerup, the bolus log is reinitialized. However, simplyreplacing the battery does not erase the bolus log when there is a validtime and date at powerup. Thus, the IOB is not lost due to a batterybeing replaced and in the exemplary embodiment, on the Activity-BasedHome screen is indicated to the user each instance the pump display isshown. This feature in the exemplary embodiment imparts to the userclearly and efficiently the amount of IOB such that the user may usethis information in their therapy. Additionally, as the IOB is not lostwhen the battery is replaced, the user may rely on bolus calculators andother indications on the display by the user interface, for theirtherapy, without interruption. However, in some embodiments, the IOB maytimeout in certain situations, for example, where the pump determinesthat power was lost for more than a threshold time or if the pump isunable to determine the date and time, or the amount of time in whichthe pump did not have power. Thus, a correct or true determination ofthe IOB may not be possible in these circumstances. However, in theexemplary embodiment of the infusion pump, the safety processormaintains the date and time of the devices. Thus, IOB recovery ispossible because of the internal clock.

Additionally, in the exemplary embodiment, the IOB may also be recoveredafter a reservoir change.

Still referring to FIGS. 10A-10E, in the exemplary embodiment, when themagnify setting is “Off” on the pump, the cursor type on theInformation-based Home screen always is displayed as Highlightregardless of the Cursor setting. This allows for the screen selectionto always be distinguishable.

In the exemplary embodiment, when delivering an extended bolus, thebolus section of the Information-Based Home screen displays the detailsof the running extended bolus, including the amount that has beendelivered, the full programmed amount, and how much time has elapsedsince the start of the extended bolus. If an extended bolus is stoppedbefore any of the extended bolus insulin has been delivered, the LastBolus information on the Home screen may be updated to reflect theprevious bolus that delivered greater than 0.0U. However, in theexemplary embodiment, where the user power cycles the pump (i.e., thepower supply is removed and replaced, this may occur when the user ischanging the battery, i.e., removing the first power supply andreplacing the first power supply with a second power supply, or removingthe first power supply and replacing it back into the pump), and anextended bolus that was stopped before any insulin was delivered is thelast bolus in the history, the Last Bolus details on the Home screenreflect that extended bolus.

Additionally, in the exemplary embodiment, the user interface displaysthe last bolus details on the Information-Based Home screen as follows:

-   -   1) The last non-zero bolus is displayed in the history if that        bolus occurred after the most recent power cycle. If there are        no boluses in the history other than a zero extended bolus, the        user interface with display “None”.    -   2) The most recent bolus in the history is displayed which may        be an extended bolus of 0.0U, if a power cycle occurred more        recently than the last bolus.    -   3) If there are no boluses in the history, the user interface        displays “None”.

Thus, in the exemplary embodiment, the user interface proves quickaccess to starting and stopping basal delivery, starting a temporarybasal, and switching basla programs on the Information-Based HomeScreen. Additionally, using the Information-Based Home screen, the userthe user interface provides quick access to bolus features (when indelivery mode). Also, the user interface displays may display agreater-than or equal to symbol to the right of the IOB label on theHome screen when any of the following are true:

-   -   1) The Bolus date for the entire action time period is not        available;    -   2) More than a predefined number, e.g., 10, boluses were given        within the action time;    -   3) There is no bolus history, and less time than the duration        specified by the user-programmable action time has passed since        the bolus log was initialized;    -   4) The IOB amount is great than a predefined number, e.g., 300.

Thus, in the exemplary embodiment, the user interface providesinformation regarding IOB where that information is safe to providewithin a predetermined threshold. That is, the user interface ensuresthe user has access only to information on which may be correct and safefor the user to base therapy decisions.

Alert and Recoverable Alarm Notification

For purposes of the current description and in the exemplary embodimentsdescribed herein, notifications include alarms, alerts and reminders.Alarms are either recoverable or non-recoverable. Alerts, reminders andrecoverable alarms notify the user of conditions that may affect normaloperation of the pump that the user may need to address. For alerts, theuser generally has some period of time in which to address thecondition; whereas recoverable alarms stop delivery and should beaddressed as soon as possible.

Non-recoverable alarms may also be referred to herein as system alarms.For recoverable alarms, the user may physically correct the problem(i.e., change the battery, replace the reservoir, etc.), and through thefeatures of the user interface, the pump may resume delivery. Systemalarms are no recoverable via the user interface. System alarms stop allprocesses, including delivery, and render the user interface unusable.

When the user interface is displaying a screen other than the Homescreen, or when a normal bolus or device prime is in progress, in theexemplary embodiments, alert and alarm notifications generated on thepump are suspended. If a normal bolus or device prime is in progress,the user interface presents the notification after the prime or normalbolus completes or is stopped, either by the user, or in the case of arecoverable alarm, the alarm condition itself stops delivery. If theuser interface is displaying a screen other than the Home screen, thenotification is suspended until the user interface transitions to theHome screen. When a recoverable alarm that stops delivery is suspended,the user interface suspends just the notification; the delivery isstopped as soon as the alarm condition is detected.

In the exemplary embodiment, when more than one notification is pending,the notifications are presented in order of priority. Also, in theexemplary embodiment, where a Companion is used with an infusion pump,all of the alerts, alarms, and reminder screen described herein aregenerated on the pump. If an alert or recoverable alarm condition occurswhen the user interface is displaying the Home screen, the userinterface produces the attention sequence on the pump and displays anotification screen that described the condition. If the pump is asleep,it wakes up to display the notification. If the pump is not fullyconfigured, notifications are suspended on the pump and are not sent tothe Companion. When the Companion is awake and displaying the Homescreen, if there is a notification being displayed on the pump, thenotification also is displayed on the Companion. The user may silencethe notification on either the pump or the Companion.

In the exemplary embodiment, when the Companion is displaying a screenother than the Home screen and the Companion receives a notificationfrom the pump, the Companion displays a flashing notification bar at thetop of the screen that indicates there is a pending notification. Whenthe user interface returns to the Home screen, if the user has notalready silenced the notification on the pump, the notification isdisplayed on the Companion.

Alert and recoverable alarm notifications are accompanied by audio orvibratory feedback on the pump, referred to herein as the attentionsequence. In the exemplary embodiment, the sequence starts as a singletone (sounded from the safety processor speaker), pause, triple tone(sounded from the H8 processor speaker) sequence (or three vibrationswhen feedback is set to vibration). The sequence repeats every 15second, in the exemplary embodiment, but in some embodiments, may repeatmore regularly or less often, until the device times out or until theuser interacts with the device. After a device time out, if there is nouser interaction within 1 minute (in other embodiments, this durationmay be longer or shorter), the user interface wakes up the pump andrepeats the notification using an escalated attention sequence: when thefeedback is set to vibration, feedback switches to audio; if thefeedback was audio, the audio sequence escalates to a single short ton(from the safety processor speaker), pause, single long (siren) tone(from the H8 processor speaker) sequence. The siren tonie is anuninterrupted succession of tones of increasing frequency. Once thefeedback has been escalated to siren, subsequent sounding of theattention sequence rotates from vibration, to audio, to siren. If theuser interacts with the device after the attention sequence has beenescalated, the next time the attention sequence is sounded, it revertsto the original attention sequence feedback. If the notification issounded for 15 minutes without user interaction while the pump is in adelivery mode, delivery is stopped and the Inactivity Alarm notificationis generated.

In the exemplary embodiments, when the user accepts the “Clear” actionselection on a notification screen, the notification is cleared and theuser interface closes the notification screen. When the pump checksagain for the alert or alarm condition, if the alert or alarm conditionstill exists, the notification is repeated.

When the user accepts the “Sleep Time” item on a notification screen,the user interface displays the SET SLEEP TIME or opens the Sleep Timeitem for editing where the user may program the sleep time value.Accepting the “Sleep” action selection on the notification screendismisses the notification for that user-programmable amount of time (15minutes to up to 12 hours, depending on the notification). The userinterface postpones checking for the condition or presenting thereminder alert again until the amount of time specified in Sleep Timehas passed. If the user changes the clock time during the sleep periodof an alert, the alert expiration time is adjusted accordingly, so thatthe alert (or check for the alert condition) is repeated when the amountof time is adjusted accordingly, so that the alert (or check for thealert condition) is repeated when the amount of time specified in theSleep Time has elapsed, regardless of the clock time. In the exemplaryembodiment, a date change has no effect on the expiration time of areminder that has been slept.

With respect to clock time and date adjustments, in the exemplaryembodiment, when the user changes the pump clock time or the date, thepump user interface adjusts the expiration time for all sleeping alerts,except the low insulin alert, to a time equal to the current expirationtime plus (if time or date was adjusted forward) or minus (if time ordate was adjusted backwards) the time or date adjustment. However, inthe exemplary embodiment, as discussed herein, to change the clock time,basal delivery must first be stopped. When basal delivery is againstarted, both sleeping pump idle and low insulin alerts are reset.

With respect to the date, when the user changes the pump date forward intime, the pump user interface generates a reminder alert for all userprogrammable reminders that either have been cleared or have not yetexpired (excluding reminders that have been slept). When the userchanges the pump clock time only (no date change) to a time earlier thanthe time of a cleared user-programmable reminder alert, the pump userinterface shall reset the reminder alert.

In the exemplary embodiment, when the pump clock time is changed to atime later than the user-programmed times of a user-programmablereminder alert that has not yet expired (i.e., has neither been clearednor slept) the user interface generates a reminder alert notification.

Where an alert, reminder or recoverable alarm condition occurs on thepump when the user interface is displaying the Home screen, the userinterface produces the attention sequence on the pump and displays thenotification screen that describes the condition. Referring now to FIG.17, examples of alert, reminder and recoverable alarm screens are shown.If the pump is in a sleep state, the user interface wakes up the pump topresent the notification. With respect to embodiments including aCompanion, in the exemplary embodiment, on the Companion, if theCompanion is awake and displaying the Home screen, the notificationscreen also is displayed on the Companion. If the Companion screen isasleep and the user wakes it up when the pump is displaying anotification, when communication with the pump resumes, the notificationalso is displayed on the Companion. The user interface allows the userto dismiss an alert or reminder for a programmable amount of time, whichthe user selects on the notification screen itself. There may be a fewexceptions, in the exemplary embodiment, of alert screen that cannot bedismissed, but only cleared.

Referring now to FIG. 18A, in the exemplary embodiment, the user opensthe SET SLEEP TIME edit item screen when the user accepts the Sleep Timeitem on an alert or reminder notification screen. The user accepts theSleep Time item to define the period of time for which to sleep thenotification. Referring now to FIG. 18B, in the exemplary embodiment,the user may program up to six reminders (however, in some embodiments,the user may program a greater number or reminders) specifying a time ofday and choosing to enable or disable the reminder. The user interfacegenerates a reminder alert for enabled reminders when the clock timechanges to the user-programmed time for the reminder. The expirationtime for all reminders that are “sleeping” is adjusted whenever the userchange the pump clock time and/or date, so that the actual amount oftime for which the alert is sleeping reflects elapsed time that matchesthe user-specified sleep time. When the user changes the clock time to atime later than the user-programmed expiration time for a reminder thathas not expired, the reminder will be detected when the user returns tothe Home screen, and the alert will be generated. Additionally, if theuser changes the date forward, the pump user interface generates analert for all enabled reminders that are not “sleeping” when the userreturns to the Home screen.

For a bolus reminder, if the start of the normal bolus delivery (eithera normal bolus, or the normal bolus portion of a dual bolus) occurredwithin 2 hours of an enables bolus reminder time, the user interfaceclears the bolus reminder alert. If the start of a normal bolus has notoccurred within 2 hours of the programmed bolus reminder time, the userinterface displays the reminder alert at the programmed time.

For a bolus reminder, if the start of a normal bolus delivery (either anormal blus, or the normal bolus portion of a dual bolus) occurred with2 hours of an enabled bolus reminder time, the user interface clears thebolus reminder alert. If the start of the normal bolus has not occurredwithin 2 hours of the programmed bolus reminder time, the user interfacedisplays the reminder alert at the programmed time.

In the exemplary embodiment, clearing a reminder does not disable thereminder. The alert condition will be detected again when the reminderexpires (when the clock changes to the user-programmed time for theenabled reminder, or a time/date change causes the reminder to expire).The user interface will generate the reminder alert notification untilthe user disables the reminder through the ALARM SETUP: REMINDERSscreen.

The user interface generates a reminder alert notification once a dayfor all user-programmable reminders that are enabled, provided the userdoes not change the clock time to a time earlier than the reminder afterthe reminder already expired; or does not change the date. When the userenables a reminder alert, if the user programmed time is later than thecurrent clock time, the user interface generates the reminder alertnotification before the end of the current 24-hour period. Conversely,when the user enables a reminder, if the user-programmed time for thereminder is earlier than the current time within the current 24-hourperiod, the user interface does not generate the reminder alert untilthe next day.

Referring to FIGS. 19A-19E, in the exemplary embodiment, with respect toalarm conditions, these include, but are not limited to: “OCCLUSIONALARM”, “RESERVOIR ALARM”, “BAD BATTERY ALARM”, “NO INSULIN ALARM”, and“INACTIVITY ALARM”.

Referring to FIGS. 20A-20I, in the exemplary embodiment, with respect toalert conditions, these include, but are not limited to: “LOW BATTERYALERT”, “LOW INSULIN ALERT”, “INACTIVITY ALERT”, “PUMP IDLE ALERT”,“STOPPED ALERT”, “CANCELLATION ALERT” (i.e., when the device times outafter a value has been changed but not saved), “CHECK BG ALERT” (whenthe CHECK BG care comment is enabled, this alert is generated by theuser interface when 2 hours has elapsed since the last cannula prime),“SITE CHANGE ALERT” alert (when this user-programmable care comment isenabled by the user, the user interface generates this alert when theamount of time between the last cannula prime and the time specified bythe user-programmable setting for the SITE CHANGE care comment Frequencyitem elapses), and “INSULIN TEMP ALERT” (when this user-programmablecare comment is enabled, the user interface generates an INSULIN TEMPALERT notification when the internal temperature of the Pump exceeds athreshold preset temperature, or is less than a threshold, presettemperature, which, in the exemplar embodiment is 96.8+/−3.6 degreesFahrenheit (36+/−2 degrees Celsius) and 37.0+/−3.6 degrees Fahrenheit(2.8+/−2 degrees Celsius) respectively. In the exemplary embodiment, theinfusion pump includes at least one temperature sensor inside the pumphousing or pump body (and either in the reusable portion or thedisposable portion of one embodiment of the infusion pump). In someembodiments, the infusion pump includes more than one temperaturesensor.

As discussed above, Reminders may be user-programmed by the user intothe user interface. In the exemplary embodiment, six reminders may beprogrammed, however, in other embodiments; a greater number of Remindersmay be user-programmed. Each Reminder includes specified time for thereminder, a message and an indication of whether the Reminder is “on” or“off”. Thus, the user may set up different Reminders in the six Reminderscreens and save those settings, whether or not any of the Reminders areturned on. On any given day, the user may turn on or off any of the sixreminders.

In the exemplary embodiment, the user interface presents a list ofprogrammable values for the Message item, which include, but are notlimited to: “Check BG”, “Wakeup”, “Basal”, “Bolus”, “Exercise”,“Meeting”, “Pickup”, “Snack”, “Meds”. Referring now to FIGS. 21A-21B, anexample of the REMINDER format screens are shown for both the 12-hourTime Format and the 24-Hour Time Format respectively.

In the exemplary embodiment, Care Comments, for example, “INSULIN TEMP”,“SITE CHANGE”, “CHECK BG”, may be individually enabled or disabled bythe user. The Care Comments generate a CARE COMMENT ALERT at thespecified time. With respect to INSULIN TEMP, as discussed above, oncethis Care Comment is enabled, a CARE COMMENT ALERT will be generatedwhen the temperature inside the pump either exceeds or goes below theset threshold. With respect to CHECK BG, this Care Comment, whenenabled, will ALERT 2 hours following a cannula prime.

Referring now to FIG. 22, with respect to the SITE CHANGE, this CareComment requires the user to select the Frequency based on the lastcannula prime. For example, if the user sets the Frequency to “3.0days”, when the SITE CHANGE care comment is enabled, the pump with SITECHANGE ALERT 3.0 days following the latest in time cannula prime.

With respect to the Care Comments, in the exemplary embodiment, the userinterface provides a “Disable All” option that allows the user todisable all Care Comment alerts. When the “Disable All” items on theOPTIONS screen is set to “Yes”, this setting overrides the individualsettings for the INSULIN TEMP, SITE CHANGE and CHECK BG Care Commentsettings.

Basal and Pump Idle

In the exemplary embodiments, the infusion pumps may deliver a “basal”of fluid or insulin, in the exemplary embodiment. In the exemplaryembodiments, the term “basal” takes on its accepted meaning of a doss ofinsulin or other fluid delivered at a “rate”, typically, Units/Hour. Theinfusion pump may be placed in an “IDLE” mode by the user through the“STOP BASAL” function of the user interface. Also, as discussed herein,the pump may place itself into IDLE mode in some circumstances. Thus,IDLE is a mode in which the pump stops delivery of the basal rate.Additionally, in IDLE mode, the pump, in the exemplary embodiment, cannot deliver any insulin, thus, the pump's delivery is suspended or“idle”.

In the exemplary embodiments, IDLE mode is required for functions wherethere delivery may be affected. Those functions may include, but are notlimited to: change to the date and/or time; change of hardware, i.e.,reservoir or battery; and/or a change in the currently active basalrate; and/or change to basal limits.

In the exemplary embodiment, once the pump is placed into IDLE mode, thepump will alert the user at an interval, e.g., every 5 minutes. This isa safety measure to ensure the user is aware the pump is not delivering.Thus, the IDLE mode is instigated by the user, and therefore, the useris aware the pump is not delivering. As the pump will remind the user ofthe IDLE mode, this ensures the user is continuously aware the pump isnot delivering.

With respect to power, in the exemplary embodiment, where the pumpsenses there is no power, the pump will notify the user as the pump willassume there has been a battery failure. However, where a user ischanging the battery (i.e., changing the power source), the user isaware that there will not be power for the time it takes to replace thebattery. In the exemplary embodiment, the user may place the pump intoIDLE while changing the battery. Thus this tells the pump that the powerfailure is expected. Thus, this failure analysis feature assists thepump in distinguishing between a power failure and an intended powersupply removal.

In this way, the pump only allows a silent shutdown (a shutdown notaccompanied by a notification from the pump) when the user places thepump in IDLE before removing the battery. As a safety, however, in theexemplary embodiments, the pump will continue its IDLE TIMER, and willalert the user at an interval, that the pump remains in idle. This alsowill occur where the battery or power source has been removed, as in theexemplary embodiment; the infusion pump includes a super capacitorback-up power supply that will prevent the infusion pump from having asilent shutdown as the infusion pump will have the power to alert theuser of the shutdown. Further, the super capacitor/back-up power supplyallows the infusion pump to notify the user at intervals during IDLEmode, even when the power supply has been removed and before a powersupply has been replaced.

Bolus

In the exemplary embodiments, the term “bolus” takes the meaning of avolume of insulin delivered upon request. The term “normal” bolusequates to a bolus where delivery commences upon request. The term“extended bolus” refers to a volume of insulin delivered over auser-programmed period of time. Thus, for example, a “normal” bolus maybe 5.5 U, where delivery is commenced at request. An “extended” bolus or5.5U may be delivered over 2 hours. A “dual” bolus is a combination of anormal bolus and an extended bolus, where the user specifies the unitsto be delivered as a normal bolus, and the time over which the extendedbolus is to be delivered. For example, a dual bolus of 6.5 U may bedelivered as follows: 1U delivered as a normal bolus, and 5.5 Udelivered over 2 hours. Additionally, in the exemplary embodiment, abolus termed a “Qbolus” refers to a QUICK BOLUS, which is a normal bolusin which the user interface immediately brings the user to a screenwhere the user simply scrolls to enter the Units for the normal bolus.

Referring now to FIGS. 23A-23B, a selection of at least some BOLUSscreens are shown. Referring first to FIG. 23A, one of the methods ofprogramming and delivering a normal bolus is by selecting the MANUALitem on the BOLUS MENU screen, which displays the BOLUS select item foredit screen. Through the BOLUS screen, the user may program a Normal,Extended or Dual bolus. The values that appear on the screen varydepending on the bolus type that the user selects.

The Extended bolus features allow the user to deliver a bolus over alonger period of time by specifying a length of time over which thebolus should be delivered. When programming an Extended bolus withoutusing a bolus calculator, the Bolus item is set to dashes. When usingthe Food only calculator, the Bolus item is set to the calculated CarbInsulin value; for a Food and Correct or Food & Correction bolus, theBolus item is set to the calculated Carb Insulin value minus the IOBamount. For any calculated bolus, the bolus amount is based on the pumpdelivery resolution (which may vary between pump embodiments) regardlessof the user-programmable bolus increment. However, when the user makes achange to a calculated value on the BOLUS screen, the user-programmedbolus increment is used. For example, if the calculated value was 0.55U, and the bolus increment settings is 1.0U, when the user edits theBolus value, a downward increment changes the value to 0.0U, and anupward increment changes the value to 1.0U.

Also, in the exemplary embodiment, if the user changes the Bolus amountfor an extended bolus to 0.0U, the Duration item is removed from theBOLUS screen. The user is allowed to accept Deliver for a 0.0U bolus,but no bolus history is generated for a 0 bolus.

A dual bolus allows the user to program and deliver a bolus thatconsists of a normal bolus that is delivered immediately, and anextended bolus that is delivered over an extended (user-defined) periodof time. When an extended bolus is currently running, the user is notallowed to program a dual bolus. If the user changes the Extended amountof 0.0U, the Duration item is removed from the BOLUS screen. The user isallowed to accept Deliver for a 0.0I bolus, but no bolus history isgenerated for a 0 bolus.

Referring now to FIG. 23B, QUICK BOLUS screens are shown. A QUICK BOLUS,or QBOLUS screen displays a programmable number, allowing the user toquickly program a normal bolus, bypassing the screen on which the bolustype is selected. In the exemplary embodiment, a QUICK BOLUS isdelivered as a Normal bolus.

In the exemplary embodiment, while the pump is in IDLE, a bolus may notbe delivered. If a user requests a bolus delivery and the pump is inIDLE, the user interface will remind the user to “Start Basal beforeblousing”. This serves as a reminder to the user that the pump is inIDLE, and thus, the user must start basal prior to blousing.

Additionally, in the exemplary embodiment, while the pump is deliveringan extended bolus, if the user requests a second extended bolus, theuser interface will display a WARNING “Extended Bolus already inprogress”. This serves to remind the user they have already programmedan extended bolus.

A correction bolus is a bolus calculated using the 1U DROP valuediscussed above, and used to calculate how much insulin to deliver tobring the user's blood glucose value to a desired level. In theexemplary embodiment, when CORRECTION is selected from the BOLUS, ifthis is done within 2 hours of the last bolus when the Insulin ProfileType setting is Rapid, or 3 hours of the lat bolus when the InsulinProfile Type setting is Short, the user interface displays the “Lessthan ⅔ hours since last bolus” WARNING. The user may still continueprogramming a correction bolus after accepting “OK”. This WARNING screenserves to inform the user of the duration since their last bolus beforethey proceed with requesting a correction.

Referring now to FIG. 24A, in the exemplary embodiment, when bolus datais not available for the entire action time period, the user interfacedisplays the IOB value on the Home screen with a greater than or equalsymbol, and generated the “IOB may not include all boluses” WARNING whenone or more of the following are true, which include, but are notlimited to:

-   -   1) When less time than the user-programmed action time has        elapsed since the bolus log was initialized, and the user        accepts the Next action selection on the BLOOD GLUCOSE screen        (in the exemplary embodiment, the bolus log is initialized when        the pump is without power for at least 15 minutes and the time        and date is set to dashes at power up);    -   2) When the number of boluses in the bolus history that occurred        with the user-programmable action time exceeds 10, or the IOB        amount is greater than 300, and the user accepts Next action        selection on the BLOOD GLUCOSE screen.    -   3) When there is no bolus history due to loss of time and date,        and the user accepts then Next action selection on the BLOOD        GLUCOSE screen.    -   4) When the user presses the back button on the BOLUS screen        that was populated with a calculated Insulin value from the        BLOOD GLUCOSE screen, and the IOB value is displayed on the BG        CALC DETAILS screen with a question mark.

Referring to FIG. 24B, in the exemplary embodiment, with respect toprogramming a bolus using one or both calculators (correction calculatoror food and correct calculator), if the Bolus amount calculates to avalue less than or equal to 0.0U, the user interface displays the “Zerobolus calculated. Cancel bolus?” CONFIRM screen.

Referring to FIG. 24C, when a bolus history has been established (which,in the exemplary embodiment, is established when at least one bolus hasbeen delivered); the user interface calculates the amount of IOB that isstill active to subtract from the calculated insulin amount for aCorrection bolus. When there is no bolus history and at least 2 hours(when insulin profile setting is Rapid) or 3 hours (when insulin profilesetting is Short) have not yet elapsed since the bolus log wasinitialized, if the user programs a bolus using the Correctioncalculator, the user interface displays the “Last bolus time unknown.Continue?” CONFIRMATION screen, when the user accepts the FOOD & CORRECTor just CORRECTION item on the BOLUS MENU screen.

Referring now to FIG. 24D, in the exemplary embodiment, the userinterface imposes a maximum bolus for all types of boluses, defined bythe user-programmable setting, Bolus Limits Maximum (SETUP:BOLUSLIMITES). The user interface displays the “Maximum bolus of [nn.nn] Uexceeded. Cancel Bolus?” CONFIRMATION screen when the user does atleast, but not limited to, any one of the following:

-   -   1) Programs a bolus using either the Correction or Food        calculator, and attempts to deliver a bolus with a calculated        insulin value that is greater than the maximum bolus limit. In        the confirmation message text, [nn.nn] U is the value of the        maximum bolus limit setting (SETUP: BOLUS LIMITS). The user        interface displays the confirmation screen when the user selects        “Next” on the FOOD or BLOOD GLUCOSE, and the bolus value        calculation is greater than the user-programmable setting for        bolus maximum limit.    -   2) Programs a dual bolus and the total bolus amount for the        combined Normal and Extended exceeds the maximum bolus amount.        The user interface displays the confirmation screen when the        user selects Deliver on the Dual Bolus screen when the combined        bolus amount is greater than the user-programmable setting for        bolus maximum limit.

As discussed above with respect to the Home screen, the user interfaceincludes readily available information regarding the IOB and the lastbolus. In the preferred embodiment, the Units and the amount of timeelapsed since the last bolus may be on the Home screen. Additionally, inthe exemplary embodiment, the user interface includes a series ofHISTORY screens. Referring now to FIG. 25, when the user accepts theHISTORY item on the BOLUS MENU or REPORTS MENU screen, the userinterface displays the HISTORY 1 of n screen. The user may clock throughhistory details for the 10 most recently delivered boluses. In otherembodiments, more than the 10 most recently delivered boluses may beavailable using this feature. The HISTORY screens show records forcompleted boluses, including normal (which includes one-button andQboluses), and extended boluses. The records are ordered by completiontime, with the most recently completed boluses displayed first. Thus,the user interface provides easy access to the last 10 bolus records,including both the Units, the type of bolus (e.g., normal, extended,etc.) and the elapsed time since the bolus was completed.

Diary and Reports

Referring now to FIG. 26, in the exemplary embodiment, the REPORTS MENUscreens provides access to the pump diaries and the bolus history. Afterthe pump is fully initialized, the user accesses the REPORTS MENU screenby selecting REPORTS on either the MAIN MENU screen, or theActivity-Based Home screen. On the pump, when engineering access isenabled, the REPORTS MENU screen includes a SEND DIARY option forsending pump logs to a PC. These are described with respect to FIGS.31-34D.

Referring now to FIG. 27, in the exemplary embodiment, when the userselects and accepts the PUMP DIARY items on the REPORTS MENU screen, theuser interface displays the PUMP DIARY screen, from which the user mayselect to view or send diaries.

Referring now to FIG. 28, in the exemplary embodiment, when the useraccepts the THERAPY item on the PUMP DIARY screen, the user interfacedisplays the Daily Therapy Summary screen for the current day (the24-hour period beginning at 12 AM in the exemplary embodiment). TheDaily Therapy Summary screen shows the total daily dose, which includesall basal and boluses delivered for that 24 hour period, and excludesvolume delivered through device primes. For an extended bolus that spansmore than one day, the total daily dose includes that portion of theextended bolus that was delivered within the 24 hour period. The usermay scroll through Daily Therapy Summary screens for up to the previous30 days. The first entry is the current calendar day; the 30^(th) entryis 30 calendar days ago. For example, if the current date is Jun. 14,2008, the first daily therapy entry is June 14 and the 30^(th) entry isMay 16. If there is no delivery data in the therapy diary for 29 daysearlier that the current date, the user interface displays Daily TherapySummary screens for the number of days from the current date to theearliest date in the therapy diary.

The therapy diary is read from the most recent date to backwards intime. While reading the therapy diary, if the user interface encountersan entry with a later date than the last event that was read, thedelivery data for that day (the day of the last event that was read) isconsidered complete with all entries are ignored until an earlier dateis found. When there is no delivery data for a given date the totaldaily dose summaries for that date are 0.0U and the % Basal item isremoved form the Therapy Summary screen.

If the diary entries indicate a basal rate other than 0 when a powerupevent was encountered, the summary details for that day are removed fromthe Therapy Summary screen, and “Invalid data” is displayed instead. Ifthe current day is the first day of pump usage and the first basaldelivery begins later than 12 AM, the period of time between 12 AM andthe first basal delivery date is represented as 0.0U/h. Similarly, theperiod of time between the time when the user accepted the THERAPY itemon the PUMP DIARY screen and the end of the current 24-hour period alsois represented as 0.0U/h.

Referring now to FIGS. 29A and 29B, in the exemplary embodiment, whenthe user accepts the EVENTS item on the PUMP DIARY screen, the userinterface displays the Event Summary screen for the pump event thatoccurred most recently. The Event Summary screen displays the date andtime that the event occurred, a description of the event, and may or maynot include additional details, depending on the event. For example,related to delivery include programmed and delivered amounts; otherevents such as extended boluses and temporary basals include durations.The user may review Event Summary screens for at least 150 events(however, in other embodiments, additional events, i.e., greater than150, may be viewable), which are ordered from the event that occurredmost recently (first entry) to the event that occurred farthest in thepast (last entry).

Referring now to FIG. 30, in the exemplary embodiment, when the useraccepts the ALARMS item on the PUMP DIARY screen, the user interfacedisplays the Alarm Summary screens for the most recent recoverable ornon-recoverable alarm. The user may scroll through Alarm Summary screensfrom past alarms.

Referring now to FIG. 31, in the exemplary embodiment, when theengineering access is enabled, the REPORTS MENU screen includes a SENDDIARY item. When the user accepts the SEND DIARY item on the REPORTSmenu screen, the user interface displays the SEND DIARY screen. Here,the user may select from a list of logs to send to a PC.

Referring now to FIG. 32, in the exemplary embodiment, when the useraccepts the SEND DIARY item on the REPORTS MENU screen, then accepts anyitem other than DONE on the SEND DIARY select item screen; the userinterface displays the “In the PC Connection Ready?” confirmationscreen. When the user interface displays the SEND DIARY screen after theuser selected “Yes” on the “Transfer Another Log?” confirmation screen,and the user selects any item other than “Done”, the “Is the PCConnection Ready?” screen is not displayed.

Referring now to FIG. 33, when engineering access is enabled, the usermay send diary logs to the PC. In the exemplary embodiment, whiletransferring a diary log, the user may choose to write the resulting logfile to the PC in ASCII format. After the user has confirmed that the PCconnection is ready by selecting “Yes” on the “Is the PC ConnectionReady?” confirmation screen, the user interface displays the “Asciiformat?” confirmation screen.

Referring now to FIG. 34A, in the exemplary embodiment, when engineeringaccess is enabled, the user may send diary logs to the PC. Whiletransferring a diary log, the user may choose to prepend configurationinformation in the resulting log file on the PC. After the user hasselected “Yes or “No” on the “Ascii format?” confirmation screen, theuser interface displays the “Prepend config info?” confirmation screen.

Referring next to FIG. 34B, in the exemplary embodiment, whenengineering access is enabled, the user may send diary logs to the PC.While transferring a diary log, the user may choose whether to includerecord numbers in the resulting log file on the PC. After the user hasselected “Yes or “No” on the “Prepend config info?” confirmation screen,the user interface displays the “Include record number?” confirmationscreen.

Referring now to FIG. 34C, in the exemplary embodiment, when engineeringaccess is enabled, the user may send diary logs to the PC. Whiletransferring a diary log, the user may choose to erase the log on thepump. The user interface transitions from the SENDING screen to the“Transfer Complete Erase Log?” confirmation screen when the datatransfer has finished.

Referring now to FIG. 34D, in the exemplary embodiment, when engineeringaccess is enabled, the user may send diary logs to the PC. Once one loghas been transferred, the user interface displays the “Transfer AnotherLog?” screen. Where the user selects “Yes”, the user interface returnsto the SEND DIARY menu.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention.

What is claimed is:
 1. A system for pairing a controller and an infusionpump, the system comprising: an infusion pump; a controller devicecomprising a touch screen display; a first user interface residing onthe controller, the user interface comprising a pairing mode forenabling wireless communication between the infusion pump and thecontroller device; and a timeout feature, wherein the pairing mode willtimeout if the pairing is not completed within approximately one minute.2. The system of claim 1, wherein the infusion pump comprising adisplay.
 3. The system of claim 2, further comprising a second userinterface residing on the infusion pump.
 4. The system of claim 3,wherein the user interface requires both the infusion pump and thecontroller to be in the pairing mode simultaneously
 5. The system ofclaim 1 wherein the pairing mode further comprising an indicator toindicate the user interface has found a device in which to pair, theindicator comprising a serial number.
 6. The system of claim 1, whereinthe pairing mode requires the infusion pump and the controller be set tothe same glucose units.
 7. The system of claim 1, wherein the infusionpump comprising a disposable housing assembly and a reusable housingassembly, the disposable housing assembly comprising at least one valveassembly wherein the at least one valve assembly is configured tocontrol the flow of infusible fluid through a fluid path in thedisposable housing assembly.
 8. The system of claim 7, furthercomprising wherein the disposable housing assembly is configured toreleasably engage the reusable housing assembly by way of a locking ringassembly, wherein the locking ring assembly is connected to the reusablehousing assembly and wherein the locking ring assembly rotates about thereusable housing assembly.
 9. The system of claim 1, wherein theinfusion pump comprising a volume sensor assembly wherein the volumesensor assembly configured to calculate the volume of infusible fluiddelivered by the infusion pump.
 10. The system of claim 1, wherein theinfusion pump comprising a mechanical control assembly comprising atleast one shape-memory actuator.
 11. A system for pairing a controllerand an infusion pump, the system comprising: an infusion pump; acontroller device; and a first user interface residing on thecontroller, the user interface comprising: a pairing mode for enablingwireless communication between the infusion pump and the controllerdevice; and a timeout feature, wherein the pairing mode will timeout anda radio is turned off if the pairing is not completed withinapproximately one minute.
 12. The system of claim 11, further comprisinga second user interface on the infusion pump.
 13. The system of claim12, further comprising wherein the user interface requires both theinfusion pump and the controller to be in the pairing modesimultaneously.
 14. The system of claim 11, wherein the infusion pumpcomprising a disposable housing assembly and a reusable housingassembly, the disposable housing assembly comprising at least one valveassembly wherein the at least one valve assembly is configured tocontrol the flow of infusible fluid through a fluid path in thedisposable housing assembly.
 15. The system of claim 12, furthercomprising wherein the disposable housing assembly is configured toreleasably engage the reusable housing assembly by way of a locking ringassembly, wherein the locking ring assembly connected to the reusablehousing assembly and wherein the locking ring assembly rotates about thereusable housing assembly.
 16. The system of claim 11, wherein theinfusion pump comprising a volume sensor assembly wherein the volumesensor assembly configured to calculate the volume of infusible fluiddelivered by the infusion pump.
 17. The system of claim 11, wherein theinfusion pump comprising a mechanical control assembly comprising atleast one shape-memory actuator.